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Hereditary Angioedema Types I and II

A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
NCT02316353 | PHASE 3 | INTERVENTIONAL

The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830_3001 (NCT01912456). Subjects who did not participate in study CSL830_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to re

Trial Information
32 Sites
126 Participants
Recruiting
6 Years to 85 Years

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Study Site
Birmingham,Alabama,United States,35209
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Scottsdale,Arizona,United States,85251
Study Site
La Jolla,California,United States,92037
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Orange,California,United States,92868
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Walnut Creek,California,United States,94598
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Chevy Chase,Maryland,United States,20815
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Cincinnati,Ohio,United States,45231
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Tulsa,Oklahoma,United States,74136
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Portland,Oregon,United States,97223
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Hershey,Pennsylvania,United States,17033
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Dallas,Texas,United States,75231
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Richmond,Virginia,United States,23298
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Campbelltown,New South Wales,Australia,2560
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Hamilton,Ontario,Canada,L8N3Z5
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Ottawa,Ontario,Canada,K1Y4G2
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Toronto,Ontario,Canada,M4V1R2
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Quebec,Canada,G1V4M6
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Plzen,Czechia,30460
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Mörfelden-Walldorf,Hesse,Germany,64546
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Berlin,Germany,10117
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Frankfurt,Germany,60596
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Mainz,Germany,55131
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Budapest,Hungary,1125
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Tel Aviv,Israel,64239
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Tel Hashomer,Israel,52621
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Catania,Italy,95123
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Milano,Italy,20157
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Cluj Napoca,Romania,400139
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Madrid,Spain,28007
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Madrid,Spain,28046
Study Site
Valencia,Spain,46026
Study Site
London,United Kingdom,E12ES

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov